Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT07101718
Status:
COMPLETED
Last Update Posted:
2025-08-03
First Post:
2025-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcomes and Risk Factors for Liver Transplantation Using Significant Fibrotic Grafts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25419}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2025-07-28', 'studyFirstSubmitQcDate': '2025-07-28', 'lastUpdatePostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival rates', 'timeFrame': 'January 2015 to December 2024', 'description': 'The overall survival of liver transplant recipients.'}], 'secondaryOutcomes': [{'measure': 'Graft survival rates', 'timeFrame': 'January 2015 to December 2024', 'description': 'The graft survival of liver transplant recipients.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Liver Transplant']}, 'descriptionModule': {'briefSummary': 'This is a multi-center study to investigate the impact of fibrotic liver greafts in liver transplant recipient.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 25419 patients underwent liver transplant were studied.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\npatients receiving liver transplantation during the period from March 2015 to March 2024\n\nExclusion Criteria:\n\n1. recipients under 18 years old\n2. re-transplantation cases\n3. multiorgan transplant cases, reduced-size or split LT cases\n4. lacking follow-up records or graft biopsy records'}, 'identificationModule': {'nctId': 'NCT07101718', 'briefTitle': 'Outcomes and Risk Factors for Liver Transplantation Using Significant Fibrotic Grafts', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Outcomes and Risk Factors for Liver Transplantation Using Significant Fibrotic Grafts: a Retrospective Cohort Analysis of the US National Database', 'orgStudyIdInfo': {'id': 'CT-2025-ZJU-OBS07'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No fibrotic', 'description': 'Liver transplant recipient receiving no fibrotic liver grafts.', 'interventionNames': ['Other: No intervention']}, {'label': 'Mild fibrotic', 'description': 'Liver transplant recipient receiving mild fibrotic liver grafts.', 'interventionNames': ['Other: No intervention']}, {'label': 'Significant', 'description': 'Liver transplant recipient receiving significant fibrotic liver grafts.', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['Mild fibrotic', 'No fibrotic', 'Significant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310006', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Zhejiang University school of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiao Xu', 'investigatorAffiliation': 'Zhejiang University'}}}}